Azibiot

Medicinal product

(Invented) name

Azibiot

Active substance (s)

Azitromicinas

Strength

20 mg/ml

Pharmaceutical form

milteliai geriamajai suspensijai

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

J01FA10, Azithromycin

Marketing authorisation holder

KRKA, d.d., Novo mesto, Slovėnija

Date of authorisation

2017-02-13

Date of renewal

2022-01-17

Documents

3600 Pakuotės lapelis milt 2022 08 30.docx

3600 Azibiot milt PCS 2024 07 06.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(3)

Procedure number

SK/H/0148/003/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 suspensijos yra	1 ml
Azitromicinas	20 mg

Packages

PAKID	NPAKID	NPAKID-7	Pack type	Pack size	Type of packaging	Proposed dispensing/classification	Marketing authorisation no.	Supply status	From	To	Package is in foreign language	From	To	Mock-up
64660	79145	1079145	buteliukas	milteliai (16,38 g), 20 ml suspensijos paruošti ir geriamasis švirkštas N1		Receptinis	LT/1/14/3600/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-01-17	Perregistruotas
2017-02-13	Registruotas